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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020170
Receipt No. R000023225
Scientific Title Study of symptom improvement effect of Esomeprazole and vonoprazan in reflux esophagitis patients
Date of disclosure of the study information 2015/12/14
Last modified on 2015/12/11

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Basic information
Public title Study of symptom improvement effect of Esomeprazole and vonoprazan in reflux esophagitis patients
Acronym The symptomatic improvement in reflux esophagitis patients
Scientific Title Study of symptom improvement effect of Esomeprazole and vonoprazan in reflux esophagitis patients
Scientific Title:Acronym The symptomatic improvement in reflux esophagitis patients
Region
Japan

Condition
Condition Reflux esophagitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the clinical effect of vonoprazan 20mg/day vs. esomeprazole 20mg/day after 4week of treatment in patients with reflux esophagitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement rates in reflux symptoms after 2 and 4 weeks of treatment
Key secondary outcomes Change in reflux symptom score after treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Esomeprazole 20mg orally once a day in the morning
Interventions/Control_2 Vonoprazan 20mg orally once a day in the morning
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Eligible, enrolled patients were who had judged to be appropriate to start the treatment of PPIs defined by GOS questionnaire and who had judged having insufficient therapeutic effects also defined by GerdQ despite continuing the conventional PPIs for four weeks or more.
Key exclusion criteria The patient that a serious heart, liver, renal function disorder, a patient developing a malignant neoplasm, a gastrointestinal tract resection, stomach esophagus junction rebuilding art, a patient having the past of the straying neurolysis, the combination taboo medicine of esomeprazole and vonoprazan
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ishihara shinichi
Organization Ishihara Gastroenterology clinic
Division name Internalmedicine
Zip code
Address 1852-1,Ikano-cho,Zentsuji City.Kagaw
TEL 0877-63-6677
Email ccy63890@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ishihara shinichi
Organization Ishihara Gastroenterology clinic
Division name Internalmedicine
Zip code
Address 1852-1,Ikano-cho,Zentsuji City.Kagawa Pref.
TEL 0877-63-6677
Homepage URL
Email ccy63890@yahoo.co.jp

Sponsor
Institute Ishihara Gastroenterology clinic
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 15 Day
Last follow-up date
2015 Year 12 Month 08 Day
Date of closure to data entry
2015 Year 12 Month 30 Day
Date trial data considered complete
2016 Year 01 Month 25 Day
Date analysis concluded
2016 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 11 Day
Last modified on
2015 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023225

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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